MelanomaNCT04234620
Intensive Medicines Monitoring Study of Toripalimab Monoclonal Injection (Tuoyi) .
An observational study of Melanoma and Lung Cance, run by Shanghai Junshi Bioscience Co., Ltd. at 25 sites in China.
Trial summary
This study was a prospective, single-arm, multi-channel, multicenter, non-interventional real-world study to evaluate the safety and efficacy of Toripalimab injection in the treatment of unresectable or metastatic melanoma with previously systemic failure . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma, Lung Cance, Breast Cancer
- What is being tested?
- Toripalimab injection
- Type of treatment
- Injection or infusion
- How many people
- 800 participants
- Where
- 25 sitesChina
- Study dates
- 15 Feb 2020to 5 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population currently included only in the melanoma cohort-unresectable or metastatic melanoma patients who had previously failed systemic therapy. If new indications are approved during the implementation of the project, patients with new indications using Toripalimab injection will also be included in this study as a new cohort.
Who may be able to join
- Patients with approved indications of Toripalimab injection;
- Patients treated with Toripalimab injection;
- Patients who agreed to participate in this study and signed an informed consent form.
Who cannot join
- Refused to participate or refused to cooperate with the procedure;
- Those who participated in the intervention study of other unapproved drugs / therapies and less than 5 half-lives after the last use of the study drugs.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
jun guo, 8610-88121122, guoj307@126.com
Cancer Hospital Chinese Academy of Medical Science
Beijing
The first affiliated Hospital of Jinlin Universtiy
Changchun
Hunan cancer hospital
Changsha
Xiangya Hospital Central South University
Changsha
Chongqing Haijiya Cancer Hospital
Chongqing
Fujian province cancer hospital
Fuzhou
Zhejiang cancer hospital
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Qilu Hospital of Shandong university
Jinan
Shandong province cancer hospital
Jinan
Affiliated Cancer Hospital of Guangxi Medical university
Nanjing
Najing Drum Tower Hospital
Nanjing
Fudan University Shanghai Cancer Center
Shanghai
Shanxi Bethune Hopital
Shanxi
The fouth Hospital of Hebei Medical University
Shijiazhuang
The Second affiliated Hospital of Suzhou Universtiy
Suzhou
Tianjin Medical University cancer institute & Hospital
Tianjin
Hubei cancer hospital
Wuhan
Tongji Medical College of Huazhong University of Science & Technology
Wuhan
Wuhan Union Hospital
Wuhan
The first affiliated Hospital of Xiamen Universtiy
Xiamen
Yinchuan Lingke Internet Hosipital
Yinchuan
Affiliated Hopital of Guangdong Medical University
Zhanjiang
Henan cancer hospital
Zhengzhou
About this study
Official title: A Prospective, Single-arm, Multicenter, Non-interventional Real-world Study of Toripalimab Injection in the Treatment of Malignant Tumors in Chinese Population.
This study was a prospective, single-arm, multi-channel, multicenter, non-interventional real-world study to evaluate the safety and efficacy of Toripalimab injection in the treatment of unresectable or metastatic melanoma with previously systemic failure . The study population currently included only in the melanoma cohort-unresectable or metastatic melanoma patients who had previously failed systemic therapy. If new indications are approved during the implementation of the project, patients with new indications using Toripalimab injection will also be included in this study as a new cohort.This study uses offline (physical hospital) and online (DTP pharmacy and Lingke (Yinchuan) Internet hospital) to collect data and information, relying on Lingke technology (Beijing) Co., Ltd. EDC (Medical Research Cloud) database for data collection and processing. The classification of adverse events was based on the general toxicity evaluation standard NCI CTCAE 5.0 of the National Institute of Oncology (Chinese version).
- Conditions
- Melanoma, Lung Cance, Breast Cancer
- Being tested
- Toripalimab injection
- Medical subject headings
- Melanoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab injectionDrug
240 mg/6 mL/vial. The recommended dose of Toripalima is 3 mg/kg, intravenous infusion every 2 weeks until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab injection | Use of Toripalimab injection in the real world Receives: Drug: Toripalimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of all ADR.
the incidence of all ADR: the number and percentage of patients with ADR, and the number of ADR events will be summarized according to the International Medical Dictionary (MedDRA) preferred terminology and adverse events General terminology Standard (NCI CTCAE5.0 Chinese version). Any ADR collected during the study will be included in the ADR summary.
Measured: 3 years
known ADR.
The incidence of known adverse reactions ((ADR)).
Measured: 3 years
The occurrence of new adverse reactions ((ADR)
The occurrence of new adverse reactions ((ADR)).
Measured: 3 years
SADR
The incidence, severity and risk factors of severe adverse reactions ((SADR)).
Measured: 3 years
Immune-related ADR
The incidence, severity and risk factors of immune-related adverse reactions.
Measured: 3 years
The incidence of adverse drug reactions ((ADR)) in special populations.
Measured: 3 years
Secondary outcomes (4)
AE
- the incidence of all adverse events (AE);
- the incidence of different severity AE;
Measured: 3 years
SAE
The incidence of severe adverse events (SAE):
Measured: 3 years
Immune-related AE.
The incidence, severity of immune-related adverse events;
Measured: 3 years
1 -, 2 -, 3-year OS rate.
Survival indicators: overall survival (OS); 1 -, 2 -, 3-year OS rate.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start15 Feb 2020 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion5 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234620
- Sponsor's protocol ID
- JS001-PMS-CO1
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter, Non-interventional Real-world Study of Toripalimab Injection in the Treatment of Malignant Tumors in Chinese Population.
- ClinicalTrials.gov ID
- NCT04234620
- Acronym / sponsor ID
- JS001-PMS-CO1
- Conditions
- Melanoma, Lung Cance, Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 15 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 5 Jul 2023 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a prospective, single-arm, multi-channel, multicenter, non-interventional real-world study to evaluate the safety and efficacy of Toripalimab injection in the treatment of unresectable or metastatic melanoma with previously systemic failure . The study population currently included only in the melanoma cohort-unresectable or metastatic melanoma patients who had previously failed systemic therapy. If new indications are approved during the implementation of the project, patients with new indications using Toripalimab injection will also be included in this study as a new cohort.This study uses offline (physical hospital) and online (DTP pharmacy and Lingke (Yinchuan) Internet hospital) to collect data and information, relying on Lingke technology (Beijing) Co., Ltd. EDC (Medical Research Cloud) database for data collection and processing. The classification of adverse events was based on the general toxicity evaluation standard NCI CTCAE 5.0 of the National Institute of Oncology (Chinese version).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab injection | – | Drug: Toripalimab injectionUse of Toripalimab injection in the real world |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population currently included only in the melanoma cohort-unresectable or metastatic melanoma patients who had previously failed systemic therapy. If new indications are approved during the implementation of the project, patients with new indications using Toripalimab injection will also be included in this study as a new cohort.
Key inclusion criteria (3 listed)
- Patients with approved indications of Toripalimab injection;
- Patients treated with Toripalimab injection;
- Patients who agreed to participate in this study and signed an informed consent form.
Key exclusion criteria (2 listed)
- Refused to participate or refused to cooperate with the procedure;
- Those who participated in the intervention study of other unapproved drugs / therapies and less than 5 half-lives after the last use of the study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toripalimab injection240 mg/6 mL/vial. The recommended dose of Toripalima is 3 mg/kg, intravenous infusion every 2 weeks until disease progression or intolerable toxicity. | Drug | Toripalimab injection |
Primary outcome
The incidence of all ADR.
Time frame: 3 years
the incidence of all ADR: the number and percentage of patients with ADR, and the number of ADR events will be summarized according to the International Medical Dictionary (MedDRA) preferred terminology and adverse events General terminology Standard (NCI CTCAE5.0 Chinese version). Any ADR collected during the study will be included in the ADR summary.
known ADR.
Time frame: 3 years
The incidence of known adverse reactions ((ADR)).
The occurrence of new adverse reactions ((ADR)
Time frame: 3 years
The occurrence of new adverse reactions ((ADR)).
SADR
Time frame: 3 years
The incidence, severity and risk factors of severe adverse reactions ((SADR)).
Immune-related ADR
Time frame: 3 years
The incidence, severity and risk factors of immune-related adverse reactions.
The incidence of adverse drug reactions ((ADR)) in special populations.
Time frame: 3 years
4 secondary outcomes
AE
Time frame: 3 years
SAE
Time frame: 3 years
Immune-related AE.
Time frame: 3 years
1 -, 2 -, 3-year OS rate.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Lung Cance, run by Shanghai Junshi Bioscience Co., Ltd. at 25 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jun guo, MD PhD (8610-88121122, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of all ADR. (time frame: 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.